US needs system for injured research subjects-panel

Tue Aug 30, 2011 1:46pm EDT

Related Topics

* International panel says compensation system needed

* HHS has proposed changes to protect research subjects

* Effort follows discovery of Guatemala syphilis study

By Alina Selyukh

WASHINGTON, Aug 30 (Reuters) - The U.S. government should create a system to compensate medical research subjects for injuries related to those trials, international reviewers said, responding to new findings of unethical behavior in a 1940s experiment in Guatemala.

The review panel presented its recommendations on Tuesday to President Barack Obama's commission on bioethics.

The presidential commission on Monday said U.S. government researchers must have known they were violating ethical standards by deliberately infecting Guatemalan prison inmates and mental patients with sexually transmitted diseases shortly after World War II. [ID:nN1E77S0XW]

The United States apologized last year for the Guatemalan experiment, which was meant to test the drug penicillin. The research was uncovered decades later by a college professor.

Guatemala has called the incident a crime against humanity, and victims have filed lawsuits against the United States.

The investigation into the Guatemalan incident has consequences for U.S. diplomacy and will impact the ethical discussion surrounding how new drugs are tested on patients, as manufacturers increasingly conduct clinical trials abroad.

The U.S. Commission for the Study of Bioethical Issues formed an international panel to address current standards of protecting research participants. The panel included experts on medical ethics and clinical research from countries including Argentina, Brazil, Guatemala, Egypt, Russia and India.

"The International Review Panel strongly felt that it was wrong and a mistake that the U.S. was an outlier (globally) in not specifying a system for compensation. You just get a lawyer and sue," said Amy Gutmann, the commission's chairwoman and president of the University of Pennsylvania.

Previous presidential bioethics commissions have already recommended the government address compensation, but no changes have emerged in the U.S. research community as a result.

The international reviewers asked the current commission to consider specific schemes to help people who may get injured while participating in medical studies.

Even before the Guatemalan experiment came into the spotlight, the U.S. Department of Health and Human Services was working on proposing changes, released in July, to its 1991 rules protecting human research subjects.

The rules have been criticized for being too stifling for low-risk studies and too loose for high-risk research. The bioethics community also has raised concerns about the application of U.S. rules in foreign countries, where a growing amount of medical research is now conducted.

The international panel on Tuesday also said governments should consider mandating a public database for all research that poses more than a minimal risk to subjects.

U.S. law does not require nonclinical research such as epidemiological studies to be included in a public database. Studies unaffiliated or not required by federal agencies also fall through the cracks, making it impossible to track in total how many people are injured or die from participation in research, experts said.

The international panel also said the commission should prioritize better use of existing laws over creating new ones.

"Whenever there's a call for a response to a scandal, there's a tendency to just add another layer of regulations ... that don't really protect patients but satisfies the need for some headlines that we're doing more," said Dr. Ezekiel Emanuel, former head of the Bioethics Department at the National Institutes of Health's Clinical Center.

The recommendations of the international review panel can be seen at r.reuters.com/paf53s . (Editing by Michele Gershberg and Tim Dobbyn)

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